The 40-week study includes 150 patients with documented patent foramen ovale closure and migraine who are randomized to either the GORE CARDIOFORM Septal Occluder or sham.
According to a new update from WL Gore & Associates, also known as Gore, patients in the RELIEF clinical study (NCT04100135) have completed their multi-month enhanced screening process and have begun entering the final randomization phase. The trial, initiated in November 2022, assesses whether closing the patent foramen ovale (PFO) using the GORE CARDIOFORM Septal Occluder may provide relief for patients with migraine.1
The GORE CARDIOFORM Septal Occluder is a permanently implanted device indicated for the percutaneous, transcatheter closure of ostium secundum atrial septal defects (ASDs) and PFO, intended to reduce the risk of recurrent ischemic stroke. It has been on the market for over a decade with over 68,000 devices sold globally and 3 different versions that cover PFOs and ASDs up to 17 mm.
"The RELIEF Clinical Study investigates whether PFO closure may reduce the number of monthly migraine headache days for select patients. No previous PFO closure migraine trial has yet included such clearly defined selection criteria designed to identify those patients expected to most likely respond to this potential, PFO-mediated mechanism," Robert Sommer, MD, principal investigator of RELIEF, said in a statement.1 "Clinical experiences have suggested a platelet-based connection between migraine and PFO, and there may be a correlation between PFO closure responsiveness and thienopyridine responsiveness. PFO closure may offer a mechanical method to reduce or eliminate this trigger factor.”
In RELIEF, investigators will assess the efficacy and safety of the implanted device, which received FDA premarket approval in 2018 for PFO closure in recurrent stroke. The trial includes 150 patients ages 18 to 55 years with documented PFO, who are randomized 1:1 to either device PFO closure or sham. Over a 40-week treatment period, patients will primarily be assessed on the reduction in mean migraine headache days, with other safety goals recorded 30 days post-procedure.
"The RELIEF Clinical Study is another example of Gore's commitment to research with the goal of improving lives,” Jake Goble, PhD, cardiac business leader for Gore’s Medical Products Division, said in a statement.1 "The study incorporates the learnings from past PFO-migraine studies targeting a patient population we hypothesize may truly benefit. We are excited to reach this milestone as we continue to pursue a potentially impactful treatment option for migraine headache relief."
Patients included in the study will have met International Classification of Headache Disorders–3 diagnostic criteria for migraine with or without aura, have at least 1 year of migraine symptom duration, and must be younger than 50 years of age at migraine onset. Patients will also have tried and failed at least 2 preventive medications, experience at least 1 migraine headache per week, and have presence of PFO as determined by transthoracic echocardiography or transesophageal echocardiography.
The efficacy and safety of PFO closure to improve migraine has been studied before, with results captured in a meta-analysis published in early 2022. In total, 3 randomized controlled trials, 1 pooled study, and 8 retrospective case series including 1165 participants were included. Compared with control intervention, PFO closure showed a significant reduction in headache frequency (odds ratio [OR], 1.5698 [95% CI, 1.0465-2.3548; P = .0293) and monthly migraine attacks and monthly migraine days (OR, 0.2594; 95% CI, 0.0790-0.4398; P = .0048). In a subgroup analysis of those who completed PFO surgery, investigators found migraine resolution in patients with aura (OR, 1.5856; 95% CI, 1.0665-2.3575; P = .0227).2